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Date: Saturday, May 18, 2024 14:18

Release 2.22
Purevax Rabies suspension for injection (NI)
 
Species: Cats
Therapeutic indication: Immunological veterinary medical products: For cats
Product:Purevax Rabies suspension for injection
Product index: Purevax Rabies
Withdrawal notes: Not applicable
Incorporating:
Qualitative and quantitative composition
Each dose of 1 ml contains:
Active substance:
Rabies recombinant canarypox virus (vCP65) ≥ 106.8FAID*50
*Fluorescent assay infectious dose 50%
Excipients:
Qualitative composition of excipients and other constituents
Potassium chloride
Sodium chloride
Potassium dihydrogen phosphate
Disodium phosphate dihydrate
Magnesium chloride hexahydrate
Calcium chloride dihydrate
Water for injections
Pharmaceutical form
Light to pink to pale yellow homogenous suspension.
Clinical particulars
Indications for use for each target species
Active immunisation of cats 12 weeks of age and older to prevent mortality due to rabies infection.
Onset of immunity: 4 weeks after the primary vaccination course.
Duration of immunity after primary vaccination: 1 year.
Duration of immunity after revaccination: 3 years.
Contraindications
None.
Special warnings
Vaccinate healthy animals only.
Special precautions for use
Special precautions for safe use in the target species:
Not applicable.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Canarypox recombinants are known to be safe for humans. Mild local and/or systemic adverse reactions related to the injection itself may be observed transitorily.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Cats.
Very rare:
(<1 animal / 10,000 animals treated, including isolated reports):
Apathy1-2, mild anorexia2, hyperthermia2-3
Injection site reactions (pain, swelling, warmth and erythema)4
Hypersensitivity reaction5
1 Slight
2 Usually lasting 1 or 2 days. Most of these reactions were noted during the 2 days following the vaccine injection.
3 Above 39.5 °C
4 Pain at palpation; limited swelling that may become nodular; usually disappearing within 1 or 2 weeks at most.
5 Which may require appropriate symptomatic treatment
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See also section “Contact details” of the package leaflet.
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction
Efficacy data are available which demonstrate that this vaccine can be administered at least 14 days before or after the administration of Boehringer Ingelheim non-adjuvanted vaccine against feline leukaemia.
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with Boehringer Ingelheim non-adjuvanted vaccines containing various combinations of feline viral rhinotracheitis, calicivirosis, panleukopenia and chlamydiosis components.
Administration routes and dosage
Subcutaneous use.
Apply usual aseptic procedures.
Administer one dose of 1 ml according to the following vaccination scheme:
Primary vaccination: 1 injection from 12 weeks of age.
Revaccination: 1 year after primary vaccination, then at intervals of up to 3 years.
Travel to countries requiring a rabies serology test: experience has shown that some vaccinated animals, while protected, may not show the 0.5 IU/ml antibody titre required by some countries. Veterinary surgeons may wish to consider two vaccinations. The best time for a blood sample to be taken is around 28 days after vaccination.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
No adverse events other than those already mentioned in section 3.6 have been observed after the administration of 10 doses. The reactions may last longer.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Official control authority batch release is required for this product.
Withdrawal periods
Not applicable.
Pharmacological particulars
Pharmaceutical particulars
Marketing Authorisation Holder (if different from distributor)
Boehringer Ingelheim Vetmedica GmbH
Binger Strasse 173
55216 Ingelheim am Rhein
Germany
Marketing Authorisation Number
EU/2/10/117/001-003
Significant changes
Date of the first authorisation or date of renewal
Date of first authorisation: 18/02/2011
Date of revision of the text
Any other information
Legal category
Legal category: POM-V
GTIN
GTIN description:2 x 1 ml
GTIN:8713942402277